Even orthopedic surgeons are not immune to metal hip replacement problems, a Consumer Reports investigation revealed. Dr. Stephen Tower, a 55 year old orthopedic surgeon from Anchorage, Alaska, experienced metal hip replacement problems after he received a DePuy ASR hip. DePuy introduced the artificial hip in 2005, and the U.S. Food and Drug Administration (“FDA”) approved it without clinical testing because it was based on a “substantially equivalent” predicate. The ASR hip is composed of a metal ball and socket, made out of chromium and cobalt. The metal-on-metal design was supposed to be a great improvement from the more traditional model with a plastic socket. Dr. Tower explained to Consumer Reports, “The main reason hips traditionally failed was because of plastic wear. The metal-on-metal hip was being promoted not only commercially but in the medical literature as being a solution for patients like me, who wanted to return to no-holds-barred physical activity.” Dr. Tower enjoyed his outdoor pursuits immediately after the metal hip replacement surgery, and was so excited about his seemingly effective new hip that he implanted various models of similar metal-on-metal devices in six of his patients.

A year later, however, Dr. Tower was experiencing serious metal hip replacement problems caused by his DePuy ASR hip implant. He reported complications including:

  • Near constant pain of his hip
  • “Notably high” levels of chromium and cobalt in his blood; and
  • Symptoms such as: “disturbed sleep, mood swings and anxiety, hearing loss, visual problems, and tinnitus.”

The symptoms were so severe at times that he was unable to work. Throughout that period, Dr. Tower “repeatedly questioned DePuy engineers, design surgeons, and sales representatives,” who told him, “Geez, Steve, we haven’t heard of this.” Meanwhile, Dr. Tower’s own research suggested something different. In fact, he uncovered evidence that the metal debris from metal-on-metal hips can cause “profound poisoning,” results that he has published since then. In 2009, Dr. Tower finally underwent revision surgery to replace the metal-on-metal hip with one made out of ceramic and plastic. His symptoms markedly improved.

Serious Metal Hip Replacement Problems Lead To Worldwide Recall

The abundance of metal hip replacement problems reported by patients with hip implants led DePuy to recall its ASR hip replacements in August 2010. An article in the British Medical Journal called it “one of the biggest disasters in orthopaedic history.” As early as three years prior to the recall, health regulators in Australia, England and Wales started to notice increasing reports of metal hip replacement problems appear in their national joint registries. The U.S. does not have such a national joint registry. Instead, the FDA has a voluntary system where patients, doctors and manufacturers can report adverse events caused by dangerous medical devices. From 2009 through 2011, the FDA received 20,518 reports of metal hip replacement problems–15,137 of which concerned the recalled ASR hips. Experts estimate that the staggering numbers represent only a fraction of actual metal hip replacement problems; many more are never reported.

Consumer Reports Advocates Reforms To Protect Patients From Dangerous Medical Devices

The advocacy arm of Consumer Reports, Consumers Union, suggests that the FDA implement the following measures to better protect and inform patients about dangerous medical devices:

  •  Implants and other “life-sustaining” medical devices should be tested as rigorously as drugs;
  • High-risk new implants and “life-sustaining” devices should not be allowed to be approved based on predicates;
  • Implants should include a “unique identifier system” so that patients can be notified of recalls and safety problems;
  • A national registry should be created to quickly spot problems and notify patients; and
  • The manufacturers should pay an increased user fee for regulatory review.

Patients Suffering From Metal Hip Replacement Problems File Thousands Of Lawsuits

The ASR hip recall has led thousands of patients to file lawsuits against DePuy. If you experienced metal hip replacement problems, you may be entitled to compensation for your medical expenses, lost wages, pain and suffering, and more. Contact a lawyer today for a free case review. The hip replacement lawyers at Bernstein Liebhard LLP will explain your legal rights and options, and guide you through the complex litigation process.

Published April 5, 2012 by